NCT03034590

Brief Summary

This study will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

October 12, 2016

Last Update Submit

January 25, 2017

Conditions

Post Stroke FatigueStroke

Outcome Measures

Primary Outcomes (2)

  • Mean MFI-20 score for case positive patients

    Describes validity of the case definition with regards to the MFI-20 questionnaire

    at inclusion in the trial

  • Mean FSS-7 score for case positive patients

    Describes validity of the case definition with regards to the FSS-7 questionnaire

    At inclusion in the trial

Secondary Outcomes (2)

  • inter rater variability of the case definition

    within a week

  • Optimal cut off score for case positiveness on MFI-20 and FSS

    at inclusion in the trial (which is the time the values used are measured)

Interventions

questionnaireOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stroke patients with a new stroke within 120 days

You may qualify if:

  • Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant.
  • Patients that have given written informed consent

You may not qualify if:

  • Patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Karsten Overgaard, MD

    Department of Neurology, Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 12, 2016

First Posted

January 27, 2017

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)